Effect of an Extract of Green Tea on Adults With Type 2 Diabetes

This study has been completed.
Sponsor:
Information provided by:
Dartmouth-Hitchcock Medical Center
ClinicalTrials.gov Identifier:
NCT00389350
First received: October 16, 2006
Last updated: October 17, 2006
Last verified: October 2006
  Purpose

The objective of this study was to determine if taking an extract of green tea for three months could improve glucose control in adults with diabetes.


Condition Intervention Phase
Diabetes
Drug: Extract of Green and Black Tea
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: The Effect of an Extract of Green Tea on Glucose Control in Adults With Type 2 Diabetes

Resource links provided by NLM:


Further study details as provided by Dartmouth-Hitchcock Medical Center:

Primary Outcome Measures:
  • HbA1c

Estimated Enrollment: 48
Study Start Date: August 2005
Estimated Study Completion Date: June 2006
Detailed Description:

Background: Recent evidence suggests that tea from Camellia Senensis (e.g., green, oolong and black tea) may have a hypoglycemic effect.

Objective: We evaluated the ability of an extract of green and black tea to improve glucose control over a three month period using a double blinded randomized multiple dose (either placebo, 375mg or 750mg) study in adults in with Type 2 Diabetes.

Patients: The 49 subjects who completed this study were predominantly whites with an average age of 65, a median duration of Diabetes of 6 years, and 80% reported using hypoglycemic medication.

Measurements: HbA1c at three months was the primary endpoint. Results: After three months the mean changes in HbA1c were +0.4, +0.3 and +0.5, in the placebo, 375mg and 750mg arms, respectively. The changes were not significantly different between study arms.

Limitations: Evaluation of a particular extract that contained components of black teas as well as green tea. Power insufficient to detect changes in HbA1c < 0.5.

Conclusions: We did not find a hypoglycemic effect of extract of green tea in adults with Type 2 Diabetes, but cannot rule out the possibility that tea may have a small beneficial effect.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adults with Diabetes not taking insulin

Exclusion Criteria:

  • pregnancy, warfarin therapy
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00389350

Locations
United States, New Hampshire
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States, 03756
Sponsors and Collaborators
Dartmouth-Hitchcock Medical Center
Investigators
Principal Investigator: Todd A MacKenzie, PhD Dartmouth-Hitchcock Medical Center
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00389350     History of Changes
Other Study ID Numbers: Hitchcock Tea 1
Study First Received: October 16, 2006
Last Updated: October 17, 2006
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on August 28, 2014